Systems and methods for rotational piercing of pre-filled medical delivery assemblies

Abstract

A pre-filled medical delivery assembly assembled and configured to allow delivery of a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient may include a multi-bevel cannula piercing element such as for rotational axial engagement to pierce a seal of the BFS vial.

What is claimed is: 
     
         1 . A pre-filled medical delivery assembly, comprising:
 a blow-fill-seal (BFS) bottle defining a collapsible fluid chamber, a neck portion, and a rounded exterior flange formed on the neck portion;   a collar defining a first end and a second end, the first end defining a mounting socket comprising an interior seat into which the rounded exterior flange is axially mated and the second end defining a hub socket comprising internal threads;   a needle hub comprising at least one external thread cooperatively mated with the internal threads of the collar to a first degree of advancement, the needle hub being coupled to a double-ended needle disposed through the needle hub, the double-ended needle comprising a multi-bevel piercing tip; and   a cap covering an administration tip of the needle and the cap comprising an interior key that is operable to drive the needle hub to advance the at least one external thread of the needle hub to a second degree of advancement with respect to the internal threads of the hub socket of the collar,
 wherein advancement of the threads to the second degree of advancement causes the multi-bevel piercing tip of the double-ended needle to pierce a seal of the BFS bottle. 
   
     
     
         2 . The pre-filled medical delivery assembly of  claim 1 , further comprising a safety shield coupled to the BFS bottle. 
     
     
         3 . The pre-filled medical delivery assembly of  claim 2 , wherein the safety shield comprises a shield base coupled to the BFS bottle and a hinge element joining the shield base to a shield element. 
     
     
         4 . The pre-filled medical delivery assembly of  claim 1 , further comprising a safety shield coupled to the collar. 
     
     
         5 . The pre-filled medical delivery assembly of  claim 1 , further comprising a safety shield comprising an annular shield base through which the BFS bottle neck portion is inserted. 
     
     
         6 . The pre-filled medical delivery assembly of  claim 5 , wherein the shield base comprises one or more mounting features that axially couple to corresponding features of the collar. 
     
     
         7 . The pre-filled medical delivery assembly of  claim 1 , wherein the interior seat comprises an interior channel rounded at a radius in the range of four to five millimeters (4-mm to 5-mm). 
     
     
         8 . The pre-filled medical delivery assembly of  claim 1 , wherein the interior seat extends radially outward into an interior wall of the mounting socket by a protrusion amount and wherein a length of the interior seat is in the range of four and three tenths times (4.3×) and five and three tenths times (5.3×) the protrusion amount. 
     
     
         9 . A medical administration assembly, comprising:
 a collar defining a first end and a second end, the first end defining a mounting socket comprising an interior seat operable to accept an exterior flange of a blow-fill-seal (BFS) bottle that is axially mated and the second end defining a hub socket comprising internal threads;   a needle hub comprising at least one external thread cooperatively mated with the internal threads of the collar to a first degree of advancement, the needle hub being coupled to a double-ended needle disposed through the needle hub, the double-ended needle comprising a multi-bevel piercing tip; and   a cap covering an administration tip of the needle and the cap comprising an interior key that is operable to drive the needle hub to advance the at least one external thread of the needle hub to a second degree of advancement with respect to the internal threads of the hub socket of the collar,
 wherein advancement of the threads to the second degree of advancement causes the multi-bevel piercing tip of the double-ended needle to pierce a seal of the collar. 
   
     
     
         10 . The medical administration assembly of  claim 9 , wherein advancement of the threads to the second degree of advancement further causes the multi-bevel piercing end of the double-ended needle to pierce a seal of the BFS bottle. 
     
     
         11 . The medical administration assembly of  claim 9 , further comprising a seal covering an opening of the mounting socket. 
     
     
         12 . A multi-bevel cannula for a pre-filled medical delivery assembly, comprising:
 an elongate hollow tube body portion defining an interior fluid conduit and a first end and a second end thereof;   the first end comprising a first bevel defining a first point for engagement with a patient; and   the second end comprise a triple-bevel defining a second point for rotational piercing of a BFS vial.   
     
     
         13 . The multi-bevel cannula of  claim 12 , wherein the cannula is made of steel. 
     
     
         14 . The multi-bevel cannula of  claim 12 , wherein the first bevel also comprises a triple-bevel. 
     
     
         15 . The multi-bevel cannula of  claim 12 , wherein the cannula comprises a 23-gauge needle. 
     
     
         16 . The multi-bevel cannula of  claim 12 , wherein the triple-bevel of the second point defines both an outside edge and an inside edge and wherein the inside edge is dulled.